SHIELD DISP. PATIENTS PONCHO GOWNS
FDA 510(k) clearance K801570 · decided 1980-07-28
Clearance details
- K-number
- K801570
- Device name
- SHIELD DISP. PATIENTS PONCHO GOWNS
- Applicant
- American Convertors Div., American Pharmaseal
- Decision
- Substantially Equivalent
- Date received
- 1980-07-08
- Decision date
- 1980-07-28
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- FYB
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE ISOLATION GOWN (K911921) | Liaoning-Usa Corp. | 1991-05-13 |
| DISPOSABLE MEDICAL GOWNS (K891820) | Bioshield, Inc. | 1989-07-24 |
| DENTAL BIB (K891053) | Dispomed, Inc. | 1989-04-12 |
| PROCEDURE & RECOVERY PATIENT SUIT (K803171) | Alba Health Care | 1981-03-04 |
| PEDIATRICS GOWN (K771929) | Convertors | 1977-11-16 |
Recalls involving this device
No recalls on record reference this clearance.